Technical Regulatory Associate Manager

Key Accountabilities:

1. Regulatory Strategy & Portfolio Management

• Develop and execute regulatory registration strategies for new products, reformulations, manufacturing changes, technology transfers, and lifecycle management by evaluating regulatory pathways, regulatory risks, business priorities, and market-specific requirements.
• Lead regulatory planning activities to support commercialization timelines, portfolio optimization, and long-term business objectives across Malaysia and Brunei.
• Provide strategic regulatory recommendations to cross-functional teams to facilitate informed business decisions while ensuring compliance with applicable regulations.
• Identify regulatory risks that may impact product launches, business continuity, or portfolio sustainability and develop appropriate mitigation strategies.
• Ensure regulatory strategies remain aligned with regional and global regulatory objectives.

2. Product Registration & Lifecycle Management

• Lead regulatory activities for product registrations, renewals, variations, notifications, product classifications, and maintenance of marketing authorizations across assigned markets.
• Establish regulatory submission plans and priorities to support business needs and ensure timely product launches.
• Oversee preparation, review, and submission of regulatory dossiers, ensuring completeness, accuracy, and compliance with regulatory requirements.
• Ensure regulatory approvals, licenses, certificates, and product registrations are maintained throughout the product lifecycle to support uninterrupted product supply.
• Monitor registration progress and proactively resolve regulatory issues that may impact project timelines.

3. Regulatory Intelligence & Risk Management

• Monitor, interpret, and assess emerging regulatory developments, legislation, and industry trends across assigned markets.
• Evaluate the business impact of regulatory changes and communicate opportunities and risks to internal stakeholders.
• Develop regulatory risk assessment and mitigation plans to ensure ongoing compliance while supporting commercial objectives.
• Provide regulatory intelligence and strategic advice to regional and global stakeholders to support business planning and innovation initiatives.

4. Regulatory Advocacy & Government Affairs

• Build and maintain effective relationships with regulatory authorities, government agencies, industry associations, and key external stakeholders.
• Represent the company in regulatory consultations, industry working groups, and professional organizations to strengthen credibility and influence regulatory policy development.
• Lead or support regulatory advocacy initiatives that protect existing business, facilitate market access, and enable future innovation.
• Coordinate responses to government inquiries, inspections, and regulatory communications.

5. Scientific & Technical Consultation

• Serve as the primary regulatory and scientific advisor to Marketing, Business Development, Product Development, Supply Chain, Quality, Legal, and other cross-functional teams.
• Provide strategic guidance on product classification, formulation, ingredient compliance, labeling, claims, advertising, packaging, and technical documentation.
• Review and approve regulatory aspects of product labels, promotional materials, and technical communications to ensure regulatory compliance.
• Support investigation and resolution of complex regulatory, technical, and product-related issues.

6. Cross-functional Leadership & Project Management

• Lead regulatory workstreams for cross-functional business initiatives to ensure regulatory requirements are integrated into project planning and execution.
• Collaborate closely with Regional and Global Regulatory Affairs teams to align local regulatory strategies with broader business objectives.
• Influence project teams and business stakeholders by providing regulatory expertise throughout the product development and commercialization process.
• Manage external regulatory consultants and service providers to ensure quality, efficiency, and timely delivery of regulatory activities.

7. Operational Excellence & Continuous Improvement

• Drive continuous improvement of regulatory processes, systems, and documentation to enhance operational efficiency and regulatory compliance.
• Develop, implement, and maintain regulatory procedures, standards, and best practices.
• Ensure regulatory information management systems and databases remain accurate, complete, and current.
• Identify opportunities to leverage digital tools and process improvements to strengthen regulatory operations.

Minimum Qualifications

• Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Food Science, Chemistry, Biology, Nutrition, or related scientific discipline.
• Registered Pharmacist (preferred where applicable).
• Minimum 8–10 years of Regulatory Affairs experience within the pharmaceutical, consumer healthcare, Health Supplement and Traditional Medicine. TM and HS product registration experience is preferred.
• Demonstrated experience developing regulatory strategies and leading product registrations across multiple product categories.
• Experience engaging with regulatory authorities, government agencies, and industry associations.
• Strong project management, stakeholder management, and communication capabilities.